In today's complex clinical research environment with global trials, various financial models and reduced resources to execute clinical trials, sponsors hire various vendors/suppliers to meet the needs of the clinical trial/clinical program. Whether the selection of vendors is in a 'preferred provider' model or not, companies find themselves with the need to select and manage vendors in a highly scrutinized regulatory landscape for vendor oversight. As regulators state, sponsors may transfer their obligations to a vendor for specific activities related to a clinical trial, but it is the sponsor who is ultimately held accountable for the work performed on their behalf. This is a requirement for 'any size' of an organization (virtual, small, medium, large).
This high-intermediate course addresses vendor management utilizing a quality management life cycle approach that supports systematic, quality-driven oversight, such as: selection of vendors, identification of risks with a vendor 'upstream' in the process of vendor management (vs. downstream - when the trial is conducted), as well as vendor oversight and management. Referencing the FDA and EMA communications for vendor oversight and the necessigy for "managing the clinical trial for quality". This course focuses on key quality principles and methods for defining, assessing and overseeing outsourced activities for quality.
Vendor Life Cycle Management, which is well-known and utilized in other industries, will be discussed in the class for benchmarking purposes.